摘要
目的建立复方辛伐他汀烟酸缓释片有关物质检查的HPLC方法。方法采用C18柱,以乙腈-0.1%磷酸溶液(50∶50)为流动相A,0.1%磷酸的乙腈溶液为流动相B,梯度洗脱,对辛伐他汀的有关物质进行检测;以乙腈-0.05mol·L-1磷酸二氢钠溶液(磷酸调pH至2.5)(1∶99)为流动相,对烟酸进行检测。结果在建立的色谱条件下,辛伐他汀、烟酸峰与其相关杂质峰均能完全分离。结论本法简便、准确、专属性强,可用于本品的有关物质检查。
OBJECTIVE To establish a HPLC methed for the determination of the related substances in com- pound simvastatin and niacin extended-release tablets. METHODS For the test of simvastatin, chromatography was carried out on a CIs column with mobile phase of A （acetonitrile-0.1% phosphoric acid, 50：50） and B （ace- tonitrile-phosphoric acid, 999：1） at the detection wavelength of 238nm by gradient program; For the analysis of niacin, chromatography was performed on a C18 column with mobile phase of acetonitrile-0.05mol· L- 1 sodium all- hydrogen phosphate solution （pH 2.5, adjusted by phosphoric acid） （1 ： 99） at the detection wavelength of 262nm. RERUSTS Under the established conditions, simvastatin, niacin and their related substances were separat- ed completely, methods have been validated and the stability test under various conditions have been per- formed. CONCLUSION METHODS This is simple,accurate and sensitive. It can be used in the quality control of compound simvastatin and niacin extended-release tablets.
出处
《海峡药学》
2012年第6期34-36,共3页
Strait Pharmaceutical Journal
